MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Unspecified Infection (1930)

Event Date 08/31/2006

Event Type  Injury  

Event Description

The patient reported that the vns has "destroyed her vagus nerve" which has caused her significant stomach problems.The patient indicated that the device has been programmed off since approximately one year following implant.The patient receives anti-nausea medication through an external port.The patient reported that the port became infected due to contaminated heparin and she was hospitalized for seventeen days.The patient reported that the physician wants to remove the vns system due to concern that the infection could go dormant around the device.The patient also reported that the lead has migrated "around her heart" and that x-rays were reviewed by three neurosurgeon's who have expressed concern regarding the location of the lead and the complexity of explant.The patient believes that it will be necessary to involve a cardiologist.No additional relevant information has been unsuccessful to date.

Event Description

Additional information was received stating that the vns patient¿s lead was protruding and that her generator and lead had migrated.The patient underwent surgery on (b)(6) 2014 to explant her generator and lead.The patient was not re-implanted due to lack of efficacy.The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

Event Description

Product analysis was completed on the lead and the generator.In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.The generator performed according to functional specifications.During the product analysis there were no anomalies found with the pulse generator.Potential contributing factors to the infection have been considered/evaluated for the generator and none were found to exist in this situation.The dhr shows that the pulse generator passed all specifications before it was released.Note that a large portion of the lead assembly (body) including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device.Note that since a large portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 3824486
• MDR Text Key: 4403343
• Report Number: 1644487-2014-01341
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2008
• Device Model Number: 302-20
• Device Lot Number: 10/19/2005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 05/21/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/21/2014; 08/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR